Contact information
Type
Scientific
Primary contact
Dr Lucia Gagliese
ORCID ID
Contact details
Department of Anaesthesia
Toronto General Hospital
200 Elizabeth Street
Toronto
M5G 2C4
Canada
+1 416 340 4296
lucia.gagliese@uhn.on.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MCT-52682
Study information
Scientific title
Acronym
Study hypothesis
Our primary aim is to determine whether perioperative NMDA-receptor antagonism has differential effects on postoperative pain, hyperalgesia and morbidity in younger and older patients. In order to achieve this aim, we propose to conduct the first randomized, double-blind placebo-controlled study designed to investigate age differences in the effects of perioperative oral administration of an NMDA-receptor antagonist (amantadine) in men undergoing radical prostatectomy. In addition, age differences in psychosocial factors and the pharmacological properties of amantadine and morphine will be measured to control for, and clarify, their contribution to the differences found.
Ethics approval
Ethics approval received from the University Health Network Research Ethics Board, Toronto, Ontario on the 12th November 2003.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Postoperative pain in radical prostatectomy
Intervention
Amantadine versus Placebo comparison.
Trial details received: 12 September 2005
Intervention type
Drug
Phase
Not Specified
Drug names
Amantadine
Primary outcome measures
Hyperalgesia and opioid consumption.
Secondary outcome measures
Assess age differences in the intensity and course of secondary hyperalgesia after surgery.
Overall trial start date
01/04/2002
Overall trial end date
31/12/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Able to read and write English
2. Age 18 - 54 years or greater than 55 years, male
3. American Society of Anesthesiologists (ASA) class 1 to 3
4. Scheduled for elective radical prostatectomy
5. Body weight between 60 and 90 kg, Body Mass Index (BMI) less than or equal to 30
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
132
Participant exclusion criteria
1. Significant Central Nervous System (CNS), respiratory, cardiac, hepatic, renal or endocrine dysfunction and/or any significant sequelae
2. Contraindications allergies to, and/or past adverse reactions to opioid analgesics or amantadine
3. History of Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) axis I disorder or cognitive dysfunction
4. History of epilepsy or other seizures
5. History of chronic pain of at least 6 months duration
6. History of long-term opioid use for chronic pain
7. History of long-term use of amantadine or other antiparkinsonian drug
8. Ingestion of antiussive medication within 48 hours before surgery
9. History of alcohol or drug dependency/abuse of at least 6 months duration
Recruitment start date
01/04/2002
Recruitment end date
31/12/2006
Locations
Countries of recruitment
Canada
Trial participating centre
Department of Anaesthesia
Toronto
M5G 2C4
Canada
Sponsor information
Organisation
University Health Network, Toronto (Canada)
Sponsor details
200 Elizabeth Street
Toronto
M5G 2C4
Canada
kfibiger@uhnres.utoronto.ca
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-52682)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary